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FDA 510(k)

XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL

K-Number: K861971 · 1986-05-30

ApplicantXomed, Inc.
Decision Date1986-05-30
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1986-05-30 under 510(k) number K861971. The device is classified under product code LXB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL?

XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL is a medical device that received FDA 510(k) clearance on 1986-05-30. The listed applicant is Xomed, Inc.. The 510(k) number is K861971.

When did XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL receive FDA 510(k) clearance?

XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL received FDA 510(k) clearance on 1986-05-30, under 510(k) number K861971.

Who is the listed applicant for XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL?

The FDA 510(k) record lists Xomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL?

The FDA product code for XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL is LXB.

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Other records listing Xomed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K002395MODEL 30 CLASSIC PNEUMATONOMETERK002987REDTRONIC XOMED MONOPOLAR ENERGIZED BLADEK002828XPS NITRO SYSTEMK002897TITANIUM MIDDLE EAR PROSTHESESK993653MICRO-FRANCE TROCARS AND ACCESSORIESK001148MEROGEL OTOLOGIC PACK

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Related Devices (Code: LXB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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